The Food and Drug Administration (FDA) is one of the executive agencies established by the United States government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA is responsible for ensuring the safety of foods, cosmetics, drugs, biologics, medical devices, and radiological products manufactured or imported into the United States. It was one of the first federal agencies to have consumer protection as its primary function. Food, drugs, cosmetics and medical devices approved by FDA are safe and effective for the human body. In nearly 100 countries such as the United States, only materials, devices and technologies approved by the FDA can be commercialized for clinical use.
FDA certification is usually divided into traditional FDA registration, FDA testing, and FDA evaluation
• FDA registration meaning: In order to ensure that the manufacturer's products exported to the United States meet the local FDA requirements, the company is required to do self-declaration guarantee process, in fact, most of the FDA registration is not tested by a third party, but the company's own guarantee.
• FDA testing: FDA testing refers more to the safety testing of food contact materials, biocompatibility testing of medical products, clinical safety testing, etc.
• FDA evaluation: In the case of cosmetics, it mainly evaluates the outer packaging and ingredient description.
1. Isolation and nursing: isolation clothes, operating clothes, lab clothes, disinfection clothes, masks, surgical caps, nurse's caps, shoe covers, bed covers, pillowcases, medical gloves, etc.
2. Examination and detection: thermometer, sphygmomanometer, stethoscope, speculum, blood needle, laboratory utensils, medical microscope, slit lamp, CT machine, nuclear magnetic resonance, etc.
3. Surgery and operation: syringes, scalp needles, ear balls, irrigators, catheters, urine bags, pre-operation leather case, catheterization kit, forceps/pliers, scissors, etc.
4, breathing and anesthesia: oxygen mask, nasal oxygen tube, tracheal intubation, sputum suction tube, etc.
5, skin and trauma: all kinds of gauze pieces, gauze rolls, all kinds of bandages, all kinds of wound dressings, medical tape, transparent adhesive, all kinds of surgical towels, etc.
6, care and recovery: cane, wheelchair, toilet, bathroom facilities, etc
1, avoid the risk of "detention" : the United States Customs has the right to "automatically detain" products that have not been registered by the FDA. If a product is exported to the United States without FDA approval, there is a risk that it will be detained and thus unable to enter the U.S. market for sale.
2, international market access certificate: FDA certification is recognized by many countries, many small countries due to their own limited administrative strength, will rely on the regulations of authoritative countries. Products approved by the FDA can be approved for direct marketing in these countries
3, enhance product competitiveness: food, drugs, cosmetics, medical devices and other products certified by the FDA are globally recognized as effective and safe products for the human body, which is the world's highest standard of product quality and effect.
